Clinical Research Support
Office for Human Research Studies (OHRS)
Resource Guidance and Regulatory Links
Ethical Principles of Human Subjects Protection
- Resource Links
- Federal Agencies Guidelines and Regulations
- Ethical Principles of Human Subjects Protection
- Certificates of Confidentiality
- Partners Policy and Guidance Links
3) Ethical Principles of Human Subjects Protection
- The Belmont Report
- Ethical Principles and Guidelines for the Protection of Human Subjects of Research (The Belmont Report) is the foundation on which the U. S. system of human subjects protection is based.
- The Belmont Report Historical Archive includes a short video, oral history transcripts and a brief history of the Belmont Report.
- IRB Guidebook
Provides help for IRB members and researchers in understanding the regulations and standards that govern research with human subjects and outlines issues to consider in designing and reviewing research proposals. - The Nuremberg Code
A 10 point code of human experimentation ethics developed during the military war crimes trial. - Declaration of Helsinki
The World Medical Association's ethical principles for medical research involving human subjects. - ICH Consolidated Guidance:
Website for International Conference on Harmonization (ICH) guidance for ethical and quality standards for research involving humans (also see FDA link for E6 Good Clinical Practice below)
- Quality Assurance Office for Clinical Trials (QACT)
- Clinical Research Unit (CRU)
- Clinical Trials Education Office (CTEO)
- Protocol Review and Monitoring System (PRMS)
